Update on October 25, 2013: The U.S. Food and Drug Administration has approved Zohydro for the management severe chronic pain. According to the FDA press release, Zohydro will be classified as a Schedule II drug with stringent security requirements. The FDA will also conduct postmarketing studies to assess the risk of abuse and addiction.
I was really hoping that the next time I blogged about Zohydro, it would be to announce the fate of this much-publicized painkiller—whether it had been approved or rejected by the Food and Drug Administration (FDA).
I certainly did not anticipate writing how Zohydro’s approval date has been pushed back yet again. But it’s true.
Originally scheduled for March 1, a press release from late last month announced that the FDA needed a few more weeks to decide. The FDA did not provide any reason for the possible delay, except for saying that the delay may last only several weeks.
For a drug that has received as much controversy as Zohydro, the delay may not forecast a favorable outcome.
The addictive potential of a pure-opioid drug like Zohydro made for some negative headlines and already cost Zogenix—the company that produced Zohydro—a hefty loss last December.
In December 2012, the FDA advisory assembly voted against recommending approval of Zohydro due to concerns about Zohydro’s potential for addiction.
In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.” –Drugfree.org
Zohydro may still have a chance, as FDA officials said they could still approve the painkiller by imposing safety restrictions.
The Background of Zohydro: What is it?
Zohydro is an extended release prescription painkiller containing pure hydrocodone, the opioid also found in Vicodin.
If you’ve ever read the label on your Vicodin prescription bottle, you’ll see that Vicodin is usually about 1 part hydrocodone to 100 parts acetaminophen. Acetaminophen may cause liver injury when used in high dosages, which is why doctors usually limit the amount of Vicodin pills you can take per day.
Although this protects your liver, you may not get complete pain relief. Many of your over-the-counter drugs also contain acetaminophen, so it’s very easy to inadvertently consume more than you should. Continually consuming too much acetaminophen will progress to permanent liver damage.
Research shows that acetaminophen toxicity is one of the leading causes of liver failure and the second most common cause of liver failure requiring transplantation. It may not kill you, but liver failure is not a condition to be scoffed.
This is why pharmaceutical companies like Zogenix are so keen to give us Zohydro.
Zohydro contains only the opioid hydrocodone. Zohydro can come in two forms: an immediate-release medication and an extended-release medication. As an extended-release medication, Zohydro has the ability to provide around-the-clock pain relief without the risk of liver failure. This combination makes Zohydro attractive to the millions of people suffering from chronic pain—as well as individuals who are addicted to painkillers.
Considering that Vicodin and Oxycontin are the two most abused prescription drugs in the nation, it’s no surprise that the FDA is hesitant to release a drug similar to both these medications.
But will the FDA decide that the benefits of Zohydro outweigh the risks? Will a new painkiller hit the market by the end of this year?
Well, if we’ve waited this long, we can certainly wait a few more weeks to hear the verdict.